Class II — Baxter Healthcare Corp.
| Recalling firm | BAXTER HEALTHCARE CORPORATION |
|---|---|
| Registered facility | View this company's 32 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer. |
| Product | Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device Device Listing: D020871 Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate. |
| Quantity | 601,230 total |
| Distribution | Worldwide Distribution - USA (nationwide), Puerto Rico, and Internationally to Brazil, Colombia, Panama, Mexico, Singapore Japan, Australia, New Zealand, Hong Kong, India, Thailand, Taiwan, and Korea. |
| Initiated | 2013-06-07 |
| Classified | 2013-06-27 |
| Terminated | 2014-06-04 |
| Recall number | Z-1609-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Baxter Healthcare Corp. (Z-1609-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65364/
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